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| ID | Type | Description | Link |
|---|---|---|---|
| P2R-REXC-06-EU | Other Identifier | Philip Morris Products S.A. |
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The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHTP 1.0 | Experimental | Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement |
|
| Conventional cigarette (CC) | Active Comparator | Ad libitum use of subject's own preferred brand of CC for 5 days in confinement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHTP 1.0 | Other | CHTP 1.0 ad libitum for 5 days in confinement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics. | 5 days |
| Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | 5 days |
| Concentration of S-phenylmercapturic Acid (S-PMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | 5 days |
| Levels of Carboxyhemoglobin (COHb) | % COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Katarzyna Jarus-Dziedzic, MD, PhD | BioVirtus Research Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioVirtus Research Site Sp. z o.o. | Kajetany | 05-830 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33154508 | Result | Tran CT, Bosilkovska M, de La Bourdonnaye G, Blanc N, Haziza C. Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial. Sci Rep. 2020 Nov 5;10(1):19227. doi: 10.1038/s41598-020-76222-y. |
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Enrolled and randomized population = 80 subjects
Number of subjects enrolled but NOT randomized (who tried the CHTP 1.0 at Day -3) = 5
Study initiated (first subject screened): 04 July 2015
At admission (Day -3), all the subjects performed a product trial of the CHTP 1.0. During the baseline period, they continued smoking their single preferred brand of CC. Then, on Day -1, subjects were randomized to one of the two study arms (CHTP 1.0 or CC) in a 1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHTP 1.0 | Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement |
| FG001 | Conventional Cigarette (CC) | Ad libitum use of subject's own preferred brand of CC for 5 days in confinement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study population consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC), and at least 1 valid non-safety assessment.
80 randomized subjects: 41 in CHTP 1.0 and 39 in CC study arms. All the randomized subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CHTP 1.0 | Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement |
| BG001 | Conventional Cigarette (CC) | Ad libitum use of subject's own preferred brand of CC for 5 days in confinement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment. | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg creat | 5 days |
|
From the informed consent form signature until the end of the safety follow-up period, up to 58 days (including a screening period of up to 42 days, a 9-day confinement period followed by a 7-day safety follow-up period (7 days after discharge of the subject or early discontinuation)).
The safety was assessed in the safety population, consisting of 85 subjects: 80 randomized subjects (41 in CHTP 1.0 and 39 in CC) and 5 subjects exposed to CHTP 1.0 during the product trial on Day -3 but not randomized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHTP 1.0 | Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment | Concussion was considered to be moderate in intensity and not related to the CHTP 1.0 or CC but to study procedures. This serious adverse event was considered to have resolved after 4 days. The subject had no ongoing medical conditions at Screening |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cam Tuan Tran | Philip Morris Products S.A. | +41 (58) 242 2620 | CamTuan.Tran@pmi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2015 | Feb 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2016 | Mar 13, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Conventional Cigarette (CC) |
| Other |
Subject's own preferred brand of CC ad libitum for 5 days in confinement |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| International Organization for Standardization (ISO) nicotine level | Count of Participants | Participants |
|
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
|
|
| Primary | Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mg creat | 5 days |
|
|
|
|
| Primary | Concentration of S-phenylmercapturic Acid (S-PMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment. | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg creat | 5 days |
|
|
|
|
| Primary | Levels of Carboxyhemoglobin (COHb) | % COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population: all randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment. However, due to sample issues such as clotting, COHb assessment results could not be generated for some of the subjects. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of saturation of hemoglobin | 5 days |
|
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| 0 |
| 41 |
| 27 |
| 41 |
| EG001 | Conventional Cigarette (CC) | Ad libitum use of subject's own preferred brand of CC for 5 days in confinement | 0 | 39 | 14 | 39 |
| EG002 | Enrolled But Not Randomized | Subjects who tried the CHTP 1.0 at Admission (Day -3) but were not randomized | 1 | 5 | 5 | 5 |
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| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
We confirm we have the contractual provisions in place which specifies that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.
The Intellectual Property rights and research results from the present study belongs to the Sponsor.
Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio) Expressed as % |
| Superiority or Other (legacy) |
Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio) Expressed as % |
| Superiority or Other (legacy) |
Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio) Expressed as % |
| Superiority or Other (legacy) |